A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People

Phase 3 Terminated 2336 enrolled Novartis Pharmaceuticals

RandomizedFactorialQuadruple-blindTreatment

Summary

This study was planned to provide new information regarding the role of aliskiren (with or without additional therapy with a diuretic or a Calcium channel blockers (CCB)) in elderly individuals (≥ 65 years) with systolic blood pressure (SBP) 130 to 159 mmHg, in preventing major cardiovascular (CV) events and on global measures of physical, executive and cognitive function.

Timeline

Start: 2011-01
Primary completion: 2012-11
Completion: 2012-11

Publications

Teo KK, Pfeffer M, Mancia G, O'Donnell M, Dagenais G, Diaz R, Dans A, Liu L, Bosch J, Joseph P, Copland I, Jung H, Pogue J, Yusuf S; Aliskiren Prevention of Later Life Outcomes trial Investigators. Aliskiren alone or with other antihypertensives in the elderly with borderline and stage 1 hypertension: the APOLLO trial. Eur Heart J. 2014 Jul;35(26):1743-51. doi: 10.1093/eurheartj/ehu079. Epub 2014 Mar 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aliskiren	Small molecule	300 mg	—
Subject	Amlodipine	Other / unclassified	5 mg	—
Subject	Hydrochlorothiazide	Unknown	25 mg	—

Indications

No indication recorded.